Z-0498-2007

Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue...

Name: Z-0498-2007 Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue...
Creator: EMD Chemicals Inc
Published: 2006-08-17
License: https://open.fda.gov/license/

EMD Millipore Corporation / initiated 2006-08-17 / Terminated

FDA source

EMD Chemicals Inc began a recall of Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes Merck KgaA 64271 Darmstadt, Germany... on 2006-08-17. The reason FDA records is "Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0498-2007
Status: Terminated
Initiated: 2006-08-17
Posted: 2007-02-17
Terminated: 2008-06-06
Recalling firm: EMD Millipore Corporation
Product: Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes Merck KgaA 64271 Darmstadt, Germany 1.19034.0002 17.08.06 1 unit UPC 4 022536 667928
Product code: J
Reason for recall: Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present.
FDA root cause: Other
Action: A Recall Letter was issued by EMD Chemicals on 8/17/2006 to discontinue product usage and for product return.
Quantity in commerce: 8 rolls
Distribution: Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico.
Product codes and lots: Item number 1.19034.0002 Lot # OC553145

Product code J

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)