Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.
FDA Recall Z-2121-2017 · Posted 2017-05-20
Recalling FirmMedtest Holdings, Inc.
Recall StatusTerminated
Product CodeJJY
Date Initiated2014-05-15
Date Terminated2017-06-02
Product Quantity132919 Vol vials
Reason for Recall
The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.
Firm Action
Customers were notified on 05/5/14by sending a technical bulletin (via email, fax, US Mail and posting on website) to all customers and distributors that had received lot 303104 of C7590, lot 303105 of C7591 or C7592 kits with either lot since product was approved to ship.
All product shipped after 05/15/2014 included the updated package inserts.
Any questions concerning the implementation of the new controls ranges may be directed to Pointe Scientific's Technical Service Department at 1-800-757-5313. Thank you for your continued support of Pointe Scientific.
Root Cause
Component design/selection
Distribution Pattern
Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.