Z-1136-2021Class II

VITROS Chemistry Products VersaTips -

Name: Z-1136-2021 VITROS Chemistry Products VersaTips -
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2021-01-14
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2021-01-14 / Terminated

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWell assays. In... on 2021-01-14. FDA classified it as Class II and gives the reason as "A deformity affecting a specific lot of VITROS Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both immunometric and competitive assays". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1136-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-14
Posted: 2021-02-19
Terminated: 2022-12-27
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWell assays. In addition, VersaTips are used to dispense R1 Reagent Fluid into cuvettes in combination with sample fluid for Micro Tips Assays.
Product code: DIP Enzyme Immunoassay, Diphenylhydantoin
Reason for recall: A deformity affecting a specific lot of VITROS Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both immunometric and competitive assays.
FDA root cause: Under Investigation by firm
Action: On 01/18/2021, Ortho Clinical Diagnostics issued an Urgent Product Correction Notification via e-mail due to a a deformity in a specific lot of VITROS Chemistry Products VersaTips. The affected product is to be no longer distributed and discarded.
Quantity in commerce: 4,062 cartons of 1,000 tips (Totaling 4,062,000 tips)
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and the country of Canada.
Product codes and lots: Lot 413420 Model(s): VITROS 250, VITROS 350, VITROS ECi, VITROS 5,1 FS, VITROS 3600, VITROS 4600, VITROS 5600, VITROS XT7600.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1136-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1136-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-19

Product code DIP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)