Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.
FDA Recall Z-2057-2014 · Posted 2014-07-15
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Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeMDB
Date Initiated2014-06-11
Date Terminated2014-08-28
Product Quantity76/50-bottle boxes
Reason for Recall
Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.
Firm Action
The recalling firm made phone calls to their customers beginning 6/11/14 with follow-up letters dated 6/12/14 being issued via regular mail requesting the affected product be destroyed. Additional customers were later identified and additional phone calls were made on 6/16/14 and recall letters dated 6/16/14 were issued via regular mail.
Root Cause
Employee error
Distribution Pattern
Distribution was made to CO, IL, IN, NE, NJ, PA, SD, and a government facility located in VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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