VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. Product Usage: The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software Version 2.8 and below; VITROS 5,1 FS Chemistry System Serial Numbers J34000016 - J34002323; VITROS 5,1 FS Chemistry System Refurbished Serial Numbers 34000133, 34000193, 34000197, 34000212, 34000285, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451, 34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557, 34000590, 34000596, 34000601, 34000631, 34000642, 34000761, 34000799, 34000805, 34000833, 34000851, 34000893, 34000946, 34000947, 34001006, 34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274, 34001297, 34001311, 34001317, 34001345, 34001378, 34001379, 34001389, 34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572, 34001612, 34001626, 34001633, 34001668, 34001755, 34001809, 34001840, 34001850, 34001875, 34001897, 34000123, 34000143, 34000191, 34000215, 34000219, 34000235, 34000251, 34000256, 34000260, 34000261, 34000319, 34000331, 34000380, 34000382, 34000406, 34000408, 34000412, 34000426, 34000431, 34000454, 34000464, 34000473, 34000501, 34000523, 34000530, 34000541, 34000542, 34000546, 34000548, 34000553, 34000558, 34000576, 34000577, 34000584, 34000585, 34000609, 34000612, 34000615, 34000616, 34000617, 34000618, 34000620, 34000625, 34000637, 34000644, 34000672, 34000744, 34000745, 34000755, 34000759, 34000776, 34000793, 34000800, 34000814, 34000831, 34000844, 34000846, 34000852, 34000856, 34000870, 34000876, 34000887, 34000892, 34000902, 34000912, 34000920, 34000938, 34000956, 34000969, 34000976, 34001007, 34001009, 34001044, 34001045, 34001052, 34001071, 34001075, 34001098, 34001099, 34001111, 34001129, 34001154, 34001161, 34001171, 34001182, 34001192, 34001195, 34001201, 34001204, 34001208, 34001212, 34001234, 34001247, 34001254, 34001271, 34001278, 34001284, 34001288, 34001289, 34001293, 34001298, 34001301, 34001302, 34001316, 34001325, 34001337, 34001340, 34001348, 34001367, 34001369, 34001399, 34001400, 34001407, 34001410, 34001416, 34001423, 34001427, 34001429, 34001457, 34001490, 34001518, 34001526, 34001551, 34001573, 34001580, 34001581, 34001582, 34001587, 34001589, 34001594, 34001610, 34001618, 34001623, 34001627, 34001673, 34001688, 34001693, 34001725, 34001738, 34001745, 34001747, 34001790, 34001796, 34001798, 34001810, 34001822, 34001831, 34001833, 34001849, 34001855, 34001859, 34001860, 34001867, 34001871, 34001872, 34001881, 34001905, 34001916, 34001923, 34001995.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Ortho-Clinical Diagnostics
- Reason for Recall:
- Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. Product Usage: The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.).
Product Codes/Lot Numbers:
Software Version 2.8 and below; VITROS 5,1 FS Chemistry System Serial Numbers J34000016 - J34002323; VITROS 5,1 FS Chemistry System Refurbished Serial Numbers 34000133, 34000193, 34000197, 34000212, 34000285, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451, 34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557, 34000590, 34000596, 34000601, 34000631, 34000642, 34000761, 34000799, 34000805, 34000833, 34000851, 34000893, 34000946, 34000947, 34001006, 34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274, 34001297, 34001311, 34001317, 34001345, 34001378, 34001379, 34001389, 34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572, 34001612, 34001626, 34001633, 34001668, 34001755, 34001809, 34001840, 34001850, 34001875, 34001897, 34000123, 34000143, 34000191, 34000215, 34000219, 34000235, 34000251, 34000256, 34000260, 34000261, 34000319, 34000331, 34000380, 34000382, 34000406, 34000408, 34000412, 34000426, 34000431, 34000454, 34000464, 34000473, 34000501, 34000523, 34000530, 34000541, 34000542, 34000546, 34000548, 34000553, 34000558, 34000576, 34000577, 34000584, 34000585, 34000609, 34000612, 34000615, 34000616, 34000617, 34000618, 34000620, 34000625, 34000637, 34000644, 34000672, 34000744, 34000745, 34000755, 34000759, 34000776, 34000793, 34000800, 34000814, 34000831, 34000844, 34000846, 34000852, 34000856, 34000870, 34000876, 34000887, 34000892, 34000902, 34000912, 34000920, 34000938, 34000956, 34000969, 34000976, 34001007, 34001009, 34001044, 34001045, 34001052, 34001071, 34001075, 34001098, 34001099, 34001111, 34001129, 34001154, 34001161, 34001171, 34001182, 34001192, 34001195, 34001201, 34001204, 34001208, 34001212, 34001234, 34001247, 34001254, 34001271, 34001278, 34001284, 34001288, 34001289, 34001293, 34001298, 34001301, 34001302, 34001316, 34001325, 34001337, 34001340, 34001348, 34001367, 34001369, 34001399, 34001400, 34001407, 34001410, 34001416, 34001423, 34001427, 34001429, 34001457, 34001490, 34001518, 34001526, 34001551, 34001573, 34001580, 34001581, 34001582, 34001587, 34001589, 34001594, 34001610, 34001618, 34001623, 34001627, 34001673, 34001688, 34001693, 34001725, 34001738, 34001745, 34001747, 34001790, 34001796, 34001798, 34001810, 34001822, 34001831, 34001833, 34001849, 34001855, 34001859, 34001860, 34001867, 34001871, 34001872, 34001881, 34001905, 34001916, 34001923, 34001995.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0643-2016
Related Recalls
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Ortho-Clinical Diagnostics
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Ortho-Clinical Diagnostics
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.
VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
Ortho-Clinical Diagnostics
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