Leukemia test kits recalled over inaccurate results with high white cell counts
Cepheid is recalling 4,032 Xpert BCR-ABL Ultra test kits because specimens with an elevated white blood cell count above 30,000 cells may cause inaccurate results.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states specimens with elevated white cell counts may produce inaccurate results, and no injuries are reported.
Plain-English summary
The Cepheid Xpert BCR-ABL Ultra, model GXBCRABL-10, is being recalled.
In vitro diagnostic test kits used with specimens that have an elevated white blood cell count, above 30,000 cells, may cause inaccurate results.
The record lists 4,032 units carrying UDI 007332940001834, across lot numbers including 1001452775, 1001457465, 1001457622, 1001459091, 1001462586, 1001462625 and 1001463944. Distribution covered a wide range of US states and countries outside the United States. The FDA has classified the action as Class II.
An inaccurate result on a diagnostic test can affect the clinical decisions made from it. The enforcement record reports no injuries. Laboratories should follow Cepheid's instructions.
The recalled product
- Product
- Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
- Manufacturer
- Cepheid
- Category
- Medical Device — Diagnostic test
- Affected units
- 4,032
Distribution
Part of a larger recall action
This product is one of 2 recalled by Cepheid 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.
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