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U.S. Department of Health and Human Services

Class 2 Device Recall Leica

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 Class 2 Device Recall Leicasee related information
Date Initiated by FirmSeptember 04, 2024
Date PostedOctober 15, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0089-2025
Recall Event ID 95323
Product Classification Microtome, cryostat - Product Code IDP
ProductLeica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples
Code Information a) Material Number 14047742467, UDI/DI 04049188053992, Serial Numbers: 492102008; b) Material Number 1491950C1US, UDI/DI 04049188002501, Serial Numbers: 432082008, 288032008, 581122008, 435082008, 380, 215012008, 427082008, 218012008, 287032008, 216012008, 291042008; c) Material Number 1491950C2US, UDI/DI 04049188002488, Serial Numbers: 524112008, 451082008, 420, 335, 476, 454, 398, 399072008; d) Material Number 1491950C3US, UDI/DI 04049188002464. Serial Numbers: 314042008, 508, 249032008, 318042008, 429, 328052008, 577122008, 407072008, 391072008, 356062008.
FEI Number 3002179321
Recalling Firm/
Manufacturer		 LEICA BIOSYSTEMS NUSSLOCH GMBH
Heidelberger Str. 17-19
Nussloch Germany
Manufacturer Reason
for Recall		As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.
FDA Determined
Cause 2		Labeling design
ActionLeica Biosystems issued an Urgent Field Action Notice to its consignees on 09/05/2024 via mail. The notice explained the problem with the device and requested the placement of a warning sticker regarding the use of flammable freezing sprays on the device and the addition of a supplemental sheet to the current IFU. For questions, please contact: Heather Jensen, Leica Biosystems, 5205 US Highway 12, Richmond, IL 60071 USA, Tel.: +1-815-298-8371, heather.jensen@leicabiosystems.com
Quantity in Commerce30 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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