FDA Device recall Z-2559-2025
Chemistry Products LAC Slides
- FDA Device
- Class II
- ongoing
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class II recall of Chemistry Products LAC Slides by Ortho Clinical Diagnostics, citing VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2559-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-29 |
| Published | 2025-09-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
Reason
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.
Identifiers
| code_info | Catalog number 8433880; UDI# 110758750004911; Coating 0130 and above, this includes Lot numbers 3533-0130-2317, 3533-0…Catalog number 8433880; UDI# 110758750004911; Coating 0130 and above, this includes Lot numbers 3533-0130-2317, 3533-0130-2717, 3533-0130-2718, 3533-0130-2719, 3533-0130-4546, 3533-0130-4605, 3533-0131-4763, 3533-0131-6114, 3533-0131-6115, 3533-0131-6116, 3533-0131-6128; Expiration date range 01-Sep-2026 to 01-Jan-2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2559-2025%22
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