Lactate test slides recalled over calibration failures delaying patient results
VITROS Chemistry Products LAC Slides from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,908 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The consequence stated is a delay in obtaining lactate results rather than erroneous results, which places this at rubric level 2.
Plain-English summary
VITROS Chemistry Products LAC Slides, catalog number 8433880, UDI 110758750004911, are being recalled for coating 0130 and above, covering the lot numbers listed in the recall notice. Each sales unit contains five cartridges of 60 slides, for 300 tests. The recall covers 2,908 units distributed nationwide in the United States.
The slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure with Condition Code TH4-63J, causing delay of lactate test results and potentially impacting patient management. QuidelOrtho identified the issue through an increase in customer complaints. The FDA classified the action as Class II.
Laboratories should check the coating and lot numbers of their slide stock against the recall notice and follow the manufacturer's instructions.
The recalled product
- Product
- Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 2,908
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ortho-Clinical Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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