Recall record at a glance
| Official record | Z-2779-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Leica Microsystems, Inc. |
| Report date | Sep 23, 2015 |
| Recall initiation date | Aug 5, 2015 |
| Quantity | 901 |
| Location | Buffalo Grove, IL, United States |
Official product description
The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
Why the product was recalled
The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure.
Distribution information
Worldwide Distribution - US including U.S. including AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, TX, VA, WA, WI, WV and District of Columbia. Internationall to AE, AT, AU , BD , BE, BF, BG,BR, CA, CL, CN, CO, CR, DE, DK, EC, EG, ES, ET, FI, FR, GB, HU, ID, IN, IT, JM, JP, KR, LK, MA, MT, MY, NL, NZ, PA, PE, PH, PL, PT, RO, RU, SA, SE, SG, TH, TR, TW, VN and ZA.
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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