FDA Medical Device Recalls (openFDA)
Alfa Wassermann, Inc: Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control.
- Recall number
- Z-0676-06
- Recalling firm
- Alfa Wassermann, Inc
- Product
- Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control.
- Status
- Terminated
- Initiated
- 2006-01-26
- Posted
- 2006-03-23
- Terminated
- 2006-04-18
- Reason
- Inaccurate test results. The magnesium values for the A31/A41 Gemcal Serum calibrator gave control results that were biased approx. 20% high.
- 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
- 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.
- Lot, serial or model codes
- Catalog Number: S1-32: Lot: A31, Exp. 2/2006 (Kit lot #F1458); A41, Exp. 1/2007 (Kit lot # F1757, F1757A, F1757B, and F1757C).
- 510(k) numbers
- ["K930104"]
- PMA numbers
- not on file
- Product code
- JIX
- Firm FEI
- 1000122044
- Firm city
- West Caldwell
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28