Z-1112-2022Class II

VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922

Name: Z-1112-2022 VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Creator: Ortho-Clinical Diagnostics, Inc
Published: 2022-03-25
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2022-03-25 / Open, Classified / root cause: design

FDA source

Ortho-Clinical Diagnostics, Inc began a recall of VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922 on 2022-03-25. FDA classified it as Class II and gives the reason as "Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1112-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-25
Posted: 2022-05-18
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Product code: CGJ Radioimmunoassay, Follicle-Stimulating Hormone
Reason for recall: Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
Root cause tag: design
FDA root cause: Device Design
Action: Ortho CLinical Diagnostics issued "URGENT PRODUCT CORRECTION NOTIFICATION" dated 3/25/22 to consignees who had been shipped VITROS FSH, LH or Prol in the previous 18 months were notified (CL2022-069) of the issue and instructed as follows: -Run daily low-level QC in duplicate to confirm acceptable performance. -If their laboratory is experiencing low end imprecision with VITROS FSH, LH or Prol Reagent, follow one of the suggested testing algorithms as described in the enclosure. o Note: If their laboratory is not experiencing low end imprecision, continue testing patient samples as usual (single replicate). -Until further notice, all future lots of the products will also be affected. -On the enclosed Credit Form, track the additional quantities of VITROS FSH, LH and/or Prol tests used due to the testing protocol. Periodically submit the form to Ortho. Ortho will credit their account. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 2502 total: 2154 US; 348 OUS
Distribution: Worldwide Distribution: US (Nationwide) OUS (Foreign): Australia Bermuda Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Netherlands Norway Portugal Russia Singapore Spain Sweden United Kingdom
Product codes and lots: Until further notice, future lots will also be affected. UDI: 10758750000302 Affected Lot Number/ Expiration Date: 3100 01-MAR-2022; 3111 25-MAR-2022; 3120 04-APR-2022; 3130 25-APR-2022; 3140 10-MAY-2022; 3145 10-MAY-2022; 3150 30-MAY-2022; 3160 09-JUN-2022; 3170 22-JUN-2022; 3180 02-AUG-2022; 3190 16-AUG-2022; 3200 06-SEP-2022; 3210 12-SEP-2022.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1112-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1112-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-18
Z-1113-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-18
Z-1114-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-18

Product code CGJ

K964720Class IVitros Immunodiagnostics Products Fsh Reagent Pack (Gem. 1005) Fsh Calibrators (Gem.c005)Johnson & Johnson Clinical Diagnostics, Inc. / cleared 1997-02-04

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)