Lactate slides in 18-slide cartridges recalled over calibration failures delaying results
VITROS Chemistry Products LAC Slides, catalog 8150112, from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,320 units are affected.
What this means for you
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 8150112, UDI 10758750004454, are being recalled for coating 0130 and above, covering the lot numbers listed in the recall notice. Each sales unit contains five cartridges of 18 slides, for 90 tests. The recall covers 2,320 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
- VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 2,320
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 (14)
- Catalog number 8150112
- UDI# 10758750004454
- Coating 0130 and above
- this includes Lot numbers 3533-0130-2947
- 3533-0130-2972
- 3533-0130-3001
- 3533-0130-3002
- 3533-0130-3048
- 3533-0130-3084
- 3533-0131-5887
- 3533-0131-5958
- 3533-0131-5962
- 3533-0131-6058
- Expiration date range 01-Oct-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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