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.
This recall has been terminated (originally issued May 11, 2020).
- Company
- Ortho-Clinical Diagnostics
- Recall Initiated
- May 11, 2020
- Terminated
- September 22, 2021
- Recall Number
- Z-2365-2020
- Quantity
- 64,697
- Firm Location
- Rochester, NY
- Official Source
- View on FDA website ↗
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
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
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
On May 11, 2020, Ortho Clinical Diagnostics, Inc. sent an Urgent Medical Device Correction Notification to their customers alerting them of important information regarding the precision of VITROS AMYL Slides. The notice stated that the imprecision affects serum, urine and QC samples, however VITROS AMYL Slides performance continues to meet its intended clinical use. The VITROS Performance Verifiers I and II Control Assay Sheet estimated within-lab SD, Range of Means (ROM) and Delta table values were re-evaluated. The Delta tables will be updated in a future revision of the Performance Verifier Training Module. In the meantime, customers were instructed to use the revised estimated within-lab SD listed in the enclosed Information sheet to evaluate their lab's quality control when using VITROS Performance Verifier I and II products. When available on the Ortho website, https://www.orthoclinicaldiagnostics.com, customers can obtain the updated VITROS Performance Verifier Control Assay Sheets and can use the revised ROM to evaluate the labs VITROS AMYL Slide quality control when using VITROS Performance Verifier I and II products. The firm explained that a review of previously reported patient results is NOT recommended. The customers were asked to Complete the Confirmation of Receipt form no later than May 19, 2020 and to forward the notification if the product was distributed outside of their facility.