Ortho-Clinical Diagnostics: Medical Device Recall in 2020 - (Recall #: Z-2365-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 11, 2020

Date Posted: June 24, 2020

Recall Number: Z-2365-2020

Event ID: 85652

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.

Status: Terminated

Product Quantity: 64,697

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

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

Voluntary or Mandated:

Voluntary: Firm initiated