Recall Z-2121-2017
Medtest Holdings, Inc. · initiated May 15, 2014
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
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.
Codes / lots: Model Number(s): C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II).
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.
FDA-determined cause: Component design/selection
Action taken
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.
Details
- Recall number
- Z-2121-2017
- Initiated
- May 15, 2014
- Posted by FDA
- May 20, 2017
- Terminated
- June 2, 2017
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Quantity
- 132919 Vol vials
- Distribution
- Nationwide
- Recalling firm
- Medtest Holdings, Inc., Canton, MI