FDA Recall
Terminated
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
Recall: Z-0498-2007
·
Initiated August 17, 2006
Recall
- Recall Number
- Z-0498-2007
- Event Number
- 37215
- Firm
- EMD Chemicals Inc
- FEI Number
- 2244894
- Product Code
- J
- Status
- Terminated
- Root Cause
- Other
- Initiated
- August 17, 2006
- Posted
- February 17, 2007
- Terminated
- June 6, 2008
- Address
- 480 S Democrat Rd, Gibbstown, NJ, 08027-1239
Description
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
Reason
Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present.
Action
A Recall Letter was issued by EMD Chemicals on 8/17/2006 to discontinue product usage and for product return.
Distribution
Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico.
Quantity
8 rolls