Leica Biosystems Cryostat recall: Labeling Error
Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and…
Why was Leica Biosystems Cryostat recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) Material Number 14047033518, UDI/DI 04049188065599, Serial Numbers: 5013012008, 3151052002, 3559082003; b) Material Number 14903050S01, UDI/DI 04049188003270, Serial Numbers: 3641, 4119012005, 5212102008, 4002102004, 3944092004, 3137042002, 3683122003, 5119, 4125022005, 4171032005, 3954092004, 2636102000, 3847052004, 4387122005, 4585092006, 4734022007, 3951092004, 3342112002, 5208082008, 4575092006, 4521052006, 2529052000, 2605, 4384102005, 4538062006, 4807, 4269062005, 2700122000, 3157052002, 4094012005, 4503042006, 3564082003, 4654, 2857072001, 3874062004, 2418022000, 3417012003, 4572082006, 3349, 3748022004, 4850072007, 4948102007, 3588092003, 3136042002, 4415122005, 4454022006, 3240072002, 5104052008, 3009012002, 4142, 4014112004, 2421022000, 3376, 3901072004, 3163052002, 3917072004, 2781042001, 4223052005, 4301092005, 5131062008, 4724022007, 2676112000, 3589092003, 4145, 4569082006, 3508, 2533062000, 4311092005, 4317092005, 4335092005, 4795052007, 5207, 4573082006, 5152072008, 5159082008, 3277092002, 3662112003, 3078032002, 3956092004, 4708022007, 4127022005, 3677122003, 4845, 3260092002, 3394, 3037012002, 4698012007, 5011012008, 2891082001, 3540072003, 3869062004, 2525052000, 4514052006, 4299072005, 3915042004, 5083, 3307102002, 5155082008, 3227072002, 3952092004, 5007012008, 5088, 2392121999, 3162052002, 3346112002, 4394, 3738022004, 3758032004, 5015012008, 4735022007, 2840062001, 3219072002, 3755022004, 4310092005, 4445012006, 5004122007, 4819062007, 3759032004, 4851, 3093032002, 3945, 3434022003, 4270062005, 4755, 4169032005, 4004102004, 2583072000, 2791/4.2001, 3396, 3824, 4655112006, 3044022002, 3832, 4853082007, 5197102008, 4193032005, 4242, 4764032007, 4781, 5018012008, 2580072000, 4952102007, 2774032001, 4797, 5171082008, 5082042008, 3548072003, 3526062003, 4774, 4320092005, 4124022005, 2943102001, 3375122002, 4801052007, 5224112008; c) Material Number 14903050S02, UDI/DI (01)04049188003201, Serial Numbers: 2624052001, 4802052007, 2633092000, 3187062002, 3908072004, 3459032003, 2890082001, 3783, 3609092003, 2627092000, 3344112002, 3795042004, 2853072001, 3401102003, 4393, 4391102005; d) Material Number 14903050S03, UDI/DI 04049188003188, Serial Numbers: 4926092007, 4644112006, 3004012002, 5226, 4958, 4518, 3644, 5070
- Product
- Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and…
- Recalling firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Quantity
- 187 units
- Distribution
- US Nationwide distribution.
- Recall date
- October 23, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)