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Terminated

Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control.

FDA Recall Z-0676-06 · Posted 2006-03-23

Recalling FirmAlfa Wassermann, Inc
Recall StatusTerminated
Product CodeJIX
Date Initiated2006-01-26
Date Terminated2006-04-18
Product Quantity22,987 kits

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.

Firm Action

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

Distribution Pattern

The kits were sent nationwide. The product was shipped to Alfa Wasserman's sister firm in Wergen, Netherlands. There are several US Navy accounts.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K930104ACE CLINICAL CHEMISTRY SYSTEMSchiapparelli Biosystems, Inc. · 1993-08-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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