FDA Medical Device Recalls (openFDA)
The Binding Site Group, Ltd.: OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
- Recall number
- Z-1327-2020
- Recalling firm
- The Binding Site Group, Ltd.
- Product
- OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
- Status
- Terminated
- Initiated
- 2019-07-29
- Posted
- not on file
- Terminated
- 2022-01-13
- Reason
- There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.
- Root cause
- Component design/selection
- Action
- On July 29, 2019, the firm issued a "Field Safety Notice" to all consignees. The firm requested consignees do the following: 1. For kit NK012.0PT.A lot 422251, please load reagents on-board the analyser and leave overnight, or alternatively for a minimum of 18 hours, prior to running the calibration and validating the curve. The Optilite analyser holds the assay reagent (R012.0PT lot 446963) in a temperature controlled reagent carousel; please leave the reagents on-board the analyser until empty (following stability advice in the insert Section 6). 2. Customers are advised that once the calibration is established and validated,the reagents must remain on the instrument until the reagent is consumed including when re-running the calibration. Investigations on NK012.0PT.A lot 422251 have shown that inversion of the reagent vials prior to re-calibration can contribute to kit control values reporting outside the specified ranges. 3. Control and calibrator vials are held in the sample handling area of the analyser. When not in use, the control and calibrator vials should be removed from the instrument, be capped to avoid evaporation and be stored at 2-sc in the refrigerator. 4. To validate the calibration curve, the control materials must be tested a minimum of once a day and should return results within 15% of the concentration(s) as stated on the accompanying QC certificate. If a control measurement is out of range when assayed with a stored curve the assay must be recalibrated. If on recalibration the control values measured with the new curve are still out of range, the instrument should be checked before repeating the assay 5. In our laboratories we have found that following the above advice allows continued and safe running of the Optilite lgM assay, if calibration issues are still experienced when following this advice please do not hesitate to contact a Binding Site representative. Advice on action to be taken by the user: " Follow advice
- Quantity
- 3294 kits
- Distribution
- CA, PA, FL, AR, SD, MA, WV, AL, GA, IL, MN, MD, AZ, NC, TN, WA, MI, NY, KY, SC, IN, OR, NE, OH, TX, VT, WA, UT, IA,
- Lot, serial or model codes
- Lot # 422251
- 510(k) numbers
- ["K191465","K191635"]
- PMA numbers
- not on file
- Product code
- CFN
- Firm FEI
- 3002808340
- Firm city
- Birmingham
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28