Aptio Automation systems with Sysmex XN-9000/XN-9100 recall
Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10…
Why was Aptio Automation systems with Sysmex XN-9000/XN-9100 recalled?
Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Serial Numbers: US: AP2.0111 AP2.0137 AP2.0190 AP2.0191 AP2.0290 AP2.0296 AP2.0321 AP2.0322 AP2.0349 AP2.0385 AP2.0398 OUS: AP2.0111 AP2.0113 AP2.0143 AP2.0170 AP2.0225 AP2.0242 AP2.0250 AP2.0259 AP2.0265 AP2.0270 AP2.0285 AP2.0295 AP2.0316 AP2.0350 AP2.0382 AP2.0388 AP2.0389 AP2.0390 AP2.0392 AP2.0448 APT.0058 APT.0065
- Product
- Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10…
- Recalling firm
- Inpeco S.A.
- Quantity
- 10 US and 22 OUS
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AK, FL, IA, LA, MA, MS, MT, NC, OH, TX, VA and the countries of AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, NETHERLANDS. NORWAY SAUDI ARABIA SOUTH KOREA SWEDEN UNITED ARAB EMIRATES
- Recall date
- September 23, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)