Z-1327-2020Class II

OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565

Name: Z-1327-2020 OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
Creator: The Binding Site Group, Ltd.
Published: 2019-07-29
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2019-07-29 / Terminated / root cause: design

FDA source

The Binding Site Group, Ltd. began a recall of OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565 on 2019-07-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1327-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-29
Posted: 2020-02-19
Terminated: 2022-01-13
Recalling firm: The Binding Site Group Ltd.
Product: OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
Product code: CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Reason for recall: 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 tag: design
FDA 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 in commerce: 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,
Product codes and lots: Lot # 422251

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1327-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1327-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19

Product code CFN

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)