Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control.
FDA device recall Z-0676-06 · posted 2006-03-23 · Terminated
Recall details
- Recalling firm
- Alfa Wassermann, Inc
- Reason for recall
- Inaccurate test results. The magnesium values for the A31/A41 Gemcal Serum calibrator gave control results that were biased approx. 20% high.
- Action taken
- Field correction letters were sent to the firm's customers via FAX on 1/14/2006-1/17/2006 and via UPS on 1/17/2006-1/19/2006. An updated letter was sent out via FAX on 1/27,30,31/2006 and via UPS on 1/30/2006 and 2/1/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- JIX
- Quantity affected
- 22,987 kits
- Distribution
- The kits were sent nationwide. The product was shipped to Alfa Wasserman's sister firm in Wergen, Netherlands. There are several US Navy accounts.
- Date initiated
- 2006-01-26
- Date posted
- 2006-03-23
- Date terminated
- 2006-04-18
- Location
- West Caldwell, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACE CLINICAL CHEMISTRY SYSTEM (K930104) | Schiapparelli Biosystems, Inc. | 1993-08-23 |