Recall Z-1371-2019
Polymer Technology Systems, Inc. · initiated January 16, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414
Codes / lots: P832
Reason for recall
Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed.
FDA-determined cause: Device Design
Action taken
The firm initially notified some of their customers from January through March 2019 with a Customer Bulletin. On March 28, 2019, the firm issued an updated Urgent Medical Device Recall letter to all affected customers. The letter alerted customers to the potential for test strips to slip out of the analyzer. Actions to be taken by the Customer/User: 1. Closely follow the instructions for proper testing. " Make sure the analyzer is sitting on a flat, stable surface. Do not perform testing with the analyzer held in the hand. " After inserting the test strip(s), do not move the analyzer until testing is complete and the test strip is removed. " As stated in the instructions for use, if an unexpected test result is given, the test should be repeated. There is no need to return or destroy the product. 2. Distributors should immediately forward this notice to all customers/users who may have received this product. 3. Acknowledge receipt of this instruction by completing the attached form, even if you do not have affected product on hand. If you have any questions, please contact Karmen Mercer, Director of Global Customer Care directly, Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time at +1 317-870-5610 or (U.S. toll-free) 877-570-8610.
Details
- Recall number
- Z-1371-2019
- Initiated
- January 16, 2019
- Terminated
- June 24, 2020
- Product code
- CHH – Enzymatic Esterase--Oxidase, Cholesterol
- Quantity
- 67643 total
- Distribution
- Domestic distribution nationwide.
- Recalling firm
- Polymer Technology Systems, Inc., Indianapolis, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1372-2019 Class II | Lipid Panel test strips (as a component of smart bundles), REF 2729, also private…Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which… | 01/16/2019Terminated |
| Z-1373-2019 Class II | CHOL+HDL+GLU test strips, REF 2412Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which… | 01/16/2019Terminated |