Leica Microsystems Recalls LPC Fine Mesh Cassettes for Closure Failure
Leica Microsystems is recalling LPC Fine Mesh Cassettes because they failed to stay closed during processing operations. The recall affects 20,160 units distributed in the US and New Zealand.
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 recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths. The hazard is a mechanical failure (failure to stay closed) without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Leica Microsystems, Inc. is recalling 20,160 units of LPC Fine Mesh Cassettes for the Leica LPC Printer. The device is intended for the storage of specimens and tissues during processing operations. The recall is being conducted because the cassettes failed to stay closed during these operations.
The affected products include specific part numbers and batch numbers, such as Part No. 14060546848 with Batch No.s 8280-10309 and 82801-0310. The recall covers units distributed nationwide in the United States, specifically to the states of Arizona and Kentucky, as well as to New Zealand.
Users of these devices should stop using the affected cassettes and contact Leica Microsystems for further instructions on the recall.
The recalled product
- Product
- LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.
- Manufacturer
- Leica Microsystems, Inc.
- Hazard
- Affected units
- 20,160
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 (20)
- 1) Part No.: 14060546848
- Batch No.s: 8280-10309
- 82801-0310
- 2) Part No.: 14060546846
- Batch No.s: 1034710114
- 3) Part No.: 14060546845
- Batch No.s: 1021420914
- 4) Part No.: 14060546933
- Batch No.s: 82801-0217
- 5) Part No.: 14060546932
- Batch No.s: 1030730112
- 1101110204
- 6) Part No.: 14060546852
- Batch No.s: 1101910322
- 7) Part No.: 14060546850
- Batch No.s: 1034710204
- 1034710328
- 1113910803
- 8) Part No.: 14060546847
- Batch No.s: 913920827
Distribution
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