ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
Class I - DangerousWhat Should You Do?
- Check if you have this product: AU480, Item Code: N3151200 N3151300 N3151400 N3151500 N3151600 N3151700 N3151800 N3151900 N3659600 N3659700 N3659900 N3660000 N3660200 N3660400 N3660600 N3660800 N3912500 AU480 OPA, Item Code: B11803 N3152300 N3152400 N3152500 N3152600 N3912600 AU680, Item Code: B12184 B12185 B12187 B12188 N3147100 N3147200 N3147300 N3147400 N3147500 N3148100 N3149800 N3153300 N3153700 N3153800 N3154000 N3658100 N3662100 N3662200 N3662400 N3662900 N3663000 N3910100 N3910400 N3910500 N3910800 N3910900 N3911200 N3911300 N3911900 AU680 OPA: B11474 N3148300 N3148600 N3148700 N3150500 N3912700 AU5800 OPA, Item Code: A94927 A94928 A94929 A94930 N9028030
- 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:
- Beckman Coulter Inc.
- Reason for Recall:
- The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
Product Codes/Lot Numbers:
AU480, Item Code: N3151200 N3151300 N3151400 N3151500 N3151600 N3151700 N3151800 N3151900 N3659600 N3659700 N3659900 N3660000 N3660200 N3660400 N3660600 N3660800 N3912500 AU480 OPA, Item Code: B11803 N3152300 N3152400 N3152500 N3152600 N3912600 AU680, Item Code: B12184 B12185 B12187 B12188 N3147100 N3147200 N3147300 N3147400 N3147500 N3148100 N3149800 N3153300 N3153700 N3153800 N3154000 N3658100 N3662100 N3662200 N3662400 N3662900 N3663000 N3910100 N3910400 N3910500 N3910800 N3910900 N3911200 N3911300 N3911900 AU680 OPA: B11474 N3148300 N3148600 N3148700 N3150500 N3912700 AU5800 OPA, Item Code: A94927 A94928 A94929 A94930 N9028030
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0153-2014
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