FDA Device recall Z-2365-2020
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vi…
- FDA Device
- Class II
- terminated
- Published 2020-06-24
On 2020-06-24 the FDA classified a Class II recall of VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vi… by Ortho Clinical Diagnostics, citing 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 Verif….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2365-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-11 |
| Published | 2020-06-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Lot #s 600203565250, 600203565563, 600203565573, 600203565902, 600203566266, 600203566278, 600203566676, 600203…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2365-2020%22
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