Z-0676-06

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

Name: Z-0676-06 Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2...
Creator: Alfa Wassermann, Inc
Published: 2006-01-26
License: https://open.fda.gov/license/

Alfa Wassermann / initiated 2006-01-26 / Terminated / root cause: manufacturing process

FDA source

Alfa Wassermann, Inc began a recall of Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control on 2006-01-26. The reason FDA records is "Inaccurate test results. The magnesium values for the A31/A41 Gemcal Serum calibrator gave control results that were biased approx. 20% high". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0676-06
Status: Terminated
Initiated: 2006-01-26
Posted: 2006-03-23
Terminated: 2006-04-18
Recalling firm: Alfa Wassermann
Product: Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control.
Product code: JIX Calibrator, Multi-Analyte Mixture
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.
Root cause tag: manufacturing process
FDA root cause: Other
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.
Quantity in commerce: 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.
Product codes and lots: Catalog Number: S1-32: Lot: A31, Exp. 2/2006 (Kit lot #F1458); A41, Exp. 1/2007 (Kit lot # F1757, F1757A, F1757B, and F1757C).

Product code JIX

K930104Class IIAce Clinical Chemistry SystemSchiapparelli Biosystems, Inc. / cleared 1993-08-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)