VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All Lot Numbers containing: GEN 38, Coating No. 0060, Expiration Date Range 03/01/13 through 07/01/13; GEN 39, Coating No. 0062, Expiration Date Range 07/01/13 through 09/01/13; GEN 40, Coating No. 0063, Expiration Date Range 10/01/13 through 12/01/13; GEN 41, Coating No. 0064, Expiration Date Range 12/01/13 through 02/01/14. [A Coating (CTG) is a unique identifier within the Lot Number of some of OCD's products. The term GEN and CTG refer to a specific segments of the reagent lot number. Current lots within expiry were all from Coatings 0060, 0062, 0063 or 0064.].
- 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:
- Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chemistry Products PHBR Slides. OCD's investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
Product Codes/Lot Numbers:
All Lot Numbers containing: GEN 38, Coating No. 0060, Expiration Date Range 03/01/13 through 07/01/13; GEN 39, Coating No. 0062, Expiration Date Range 07/01/13 through 09/01/13; GEN 40, Coating No. 0063, Expiration Date Range 10/01/13 through 12/01/13; GEN 41, Coating No. 0064, Expiration Date Range 12/01/13 through 02/01/14. [A Coating (CTG) is a unique identifier within the Lot Number of some of OCD's products. The term GEN and CTG refer to a specific segments of the reagent lot number. Current lots within expiry were all from Coatings 0060, 0062, 0063 or 0064.].
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1152-2013
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