Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitativ
FDA device recall Z-0671-2020 · posted 2019-12-12 · Terminated
Recall details
- Recalling firm
- The Binding Site Group, Ltd.
- Reason for recall
- Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
- Action taken
- On 02/19/2019 an "URGENT FIELD SAFETY NOTICE" was communicated to the US customers informing them of an observed deterioration of the CRP NK044.OPT.A reagent material, lot number 437705 and that the Recalling firm has made the decision to remove the affected product lot from the market.. The Customers are instructed to: -Discontinue using the product immediately and to remove any remaining affected reagents from the Optilite instrument. -Dispose of any remaining product at the customer's facility following local regulations, -The Recalling Firm considers this issue is unlikely to impact on medical management, they are recommending that the information be discussed with the customer's medical director so that potential Impact of the issue is considered on a local level. -Customer are to complete, sign and return the E-Back Form TSWS18 to Technical.support@bindingsite.com or to their local representative within one week of receiving the notification. A witness signature of the kit disposal is required on the E-Back Form. The notification also states to: -Distribute the notice to all those who need to be aware of the matter within the customer's organization. -Transfer the notice to any other organization on which the recall action has impacted. -Maintain awareness on the notice and resulting action for appropriate period to ensure effectiveness of the recommended actions. For any questions or further information - contact the local firm representative or call +44(0) 1214569696
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- DCN
- Quantity affected
- 10 kits
- Distribution
- US Nationwide distribution in the states of CA and GA. OUS not provided due to product being manufacture OUS
- Date initiated
- 2019-02-19
- Date posted
- 2019-12-12
- Date terminated
- 2021-04-27
- Location
- Birmingham, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls (K172868) | The Binding Site Group , Ltd. | 2018-02-28 |