Z-0671-2020Class II

Optilite C-Reactive Protein Kit -

Name: Z-0671-2020 Optilite C-Reactive Protein Kit -
Creator: The Binding Site Group, Ltd.
Published: 2019-02-19
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2019-02-19 / Terminated / root cause: manufacturing process

FDA source

The Binding Site Group, Ltd. began a recall of Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive... on 2019-02-19. FDA classified it as Class II and gives the reason as "Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0671-2020
Classification: Class II
Status: Terminated
Initiated: 2019-02-19
Posted: 2019-12-12
Terminated: 2021-04-27
Recalling firm: The Binding Site Group Ltd.
Product: Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.
Product code: DCN System, Test, C-Reactive Protein
Reason for recall: Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: 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 [email protected] 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
Quantity in commerce: 10 kits
Distribution: US Nationwide distribution in the states of CA and GA. OUS not provided due to product being manufacture OUS
Product codes and lots: Model Number: NK044.OPT.A Lot 437705 UDI 05051700018449 Medical Device Listing number D317086

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0671-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0671-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-12

Product code DCN

K172868Class IIOptilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsThe Binding Site Group , Ltd. / cleared 2018-02-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)