Z-1136-2021 Class II Terminated
FDA device recall Z-1136-2021 was initiated by Ortho-Clinical Diagnostics, Inc. on January 14, 2021 and is designated Class II. 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. The recall status is terminated (terminated December 27, 2022). Affected quantity: 4,062 cartons of 1,000 tips (Totaling 4,062,000 tips).
Recall Details
- Product Type
- Devices
- Report Date
- March 3, 2021
- Initiation Date
- January 14, 2021
- Termination Date
- December 27, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,062 cartons of 1,000 tips (Totaling 4,062,000 tips)
Product Description
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.
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.
Distribution Pattern
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.
Code Information
Lot 413420 Model(s): VITROS 250, VITROS 350, VITROS ECi, VITROS 5,1 FS, VITROS 3600, VITROS 4600, VITROS 5600, VITROS XT7600.