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U.S. Department of Health and Human Services

Class 3 Device Recall Anaerotest

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  Class 3 Device Recall Anaerotest see related information
Date Initiated by Firm August 17, 2006
Date Posted February 17, 2007
Recall Status1 Terminated 3 on June 06, 2008
Recall Number Z-0498-2007
Recall Event ID 37215
Product Classification Micro Test Rolls - Product Code J TX
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
Code Information Item number 1.19034.0002 Lot # OC553145
Recalling Firm/
EMD Chemicals Inc
480 S Democrat Rd
Gibbstown NJ 08027-1239
For Additional Information Contact Joseph Scheollkopff
Manufacturer 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 2
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.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.