Z-2365-2020 Class II Terminated
Recalled by Ortho-Clinical Diagnostics
— Rochester, NY
FDA device recall Z-2365-2020 was initiated by Ortho-Clinical Diagnostics on May 11, 2020 and is designated Class II. Reason for recall: Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheet… The recall status is terminated (terminated September 22, 2021). Affected quantity: 64,697.
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2020
- Initiation Date
- May 11, 2020
- Termination Date
- September 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64,697
Product Description
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
Reason for Recall
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
Distribution Pattern
Worldwide distribution - US Nationwide including in the statesof Maine, Massachusetts, Vermont, Connecticut, New Jersey, New York, Pennsylvania, Washington DC, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Florida, Alabama, Tennessee, Missouri, Mississippi, Kentucky, Ohio, Indiana, Michigan, Iowa, Wisconsin, Minnesota, South Dakota, North Dakota, Montana, Illinois, Kansas, Nebraska, Louisiana, Arkansas, Oklahoma, Texas, Colorado, Idaho, Utah, Arizona, New Mexico, California, Hawaii, Oregon , Washington, and Alaska
Code Information
Lot #s 600203565250, 600203565563, 600203565573, 600203565902, 600203566266, 600203566278, 600203566676, 600203567387, 600203567388, 600203567389, 600303570323, 600303570338, 600303570824, 600303570830, 600303570847, 600303570848, 600303577945, 600303578593, 600303579040, 600303579041, 600303579565, 600303579566, 600303579616, 600503581489, 600503581495, 600503582261, 600503582262, 600503582269, 600503582570, 600503582607, 600503583117, 600503584003, 600503584704, 600503584705, 600503584706, 600503584987, 600503585015, 600503585951, 600503585957, 600503586204, 600503586207, 600503586219, 600603594331, 600603596567, 600603596601, 600603596692, 600603596693, 600803638425, 600803638426, 600803638483, 600803638489, 600803638490, 600803639060, 600803639078, 600803639091