Class 3 Device Recall Anaerotest

• Date Initiated by Firm: August 17, 2006
• Date Posted: February 17, 2007
• Recall Status: Terminated 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/ Manufacturer: EMD Chemicals Inc; 480 S Democrat Rd; Gibbstown NJ 08027-1239
• For Additional Information Contact: Joseph Scheollkopff; 856-423-6300
• 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: 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.

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.