Recall Z-1403-2013 ยท NBW System, Test, Blood Glucose, Over The Counter
Polymer Technology Systems, Inc.
PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood
| Date | May 25, 2013 (initiated Apr 4, 2013) |
| Status | Terminated |
| Reason | Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk. |
| Root cause | Under Investigation by firm |
| Action | Polymer Technology Systems sent a Field Correction Action letters dated April 4, 2013 to distributors and customers. The letter identified the affected product, problem and actions to be taken. The letter directed customers to discontinue use and dispose of remaining inventory of recalled product. Customers were asked to acknowledge and confirm recall directions were follwed by fax to 1-317-870-5608. |
| Quantity | 7048 total, 3499 in USA |
| Distribution | Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: UK, CHL, ENG, BEL, ITA, TKY, BEL, LIT, LTV, EGY, SPG, HOK, SWE, MEX, UAE, COR, ISR, MAL, AUS, POR, POL, SLN and STQ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013068 | BIOSCANNER 2000 Polymer Technology Systems, Inc., Nov 20, 2001 |