Recall Z-0499-2007
EMD Chemicals Inc · initiated August 17, 2006
Product
Anaerotest;Microbiology , 50 test strips 1.15112 Store dry and tightly closed. Store at + 15 C to +25C Merck IVD 64271 Darmstadt, Germany
Codes / lots: Item # 1.15112.0001 Lot # OC553145
Reason for recall
Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present
FDA-determined cause: Other
Action taken
A Recall Letter was issued by EMD Chemicals on 8/17/2006 to discontinue product usage and for product return.
Details
- Recall number
- Z-0499-2007
- Initiated
- August 17, 2006
- Posted by FDA
- February 17, 2007
- Terminated
- June 6, 2008
- Quantity
- 800 packages of 50 strips each.
- Distribution
- Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico.
- Recalling firm
- EMD Chemicals Inc, Gibbstown, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0498-2007 | Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6…Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment… | 08/17/2006Terminated |