X-CAL, Sysmex E-Check, 8Check 3WP X-TRA Control, Sysmex SCS-1000 Universal Calibrator, XN CHECK, XN CAL, XN CAL PF, XN CAL - CUSTOMER SET, XN CAL PF - CUSTOMER SET, and XN-L CHECK (2018-05-08)
In plain language
This recall involves several Sysmex hematology controls and calibrators sold in Canada. They are being recalled because they may provide inaccurate platelet counts if not mixed sufficiently. Healthcare professionals should stop using the products and follow the instructions in the official notice.
What to do
- Stop using the affected products immediately.
- Check the lot or serial numbers of your products.
- Remix the product and repeat analysis as instructed in the official notice.
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Affected products
X-CAL
Model: 110-4008-0, 110-4009-0
Lot: beginning with 7283
Sysmex E-Check
Model: 199-4004-1, 199-5001-0, 199-5002-0, 201-6001-0, 201-6002-0, 201-6003-0, 201-6004-0
Lot: beginning with 7269, beginning with 7277, beginning with 7305
8Check 3WP X-TRA Control
Model: 14030040, 14030060
Lot: beginning with 7255
Sysmex SCS-1000 Universal Calibrator
Model: 160-4002-0
Lot: beginning with 7283
XN Check
Model: 213499
Lot: beginning with 7261
XN CAL
Model: XN CAL
Lot: beginning with 7282
XN CAL PF
Model: XN CAL PF
Lot: beginning with 7282
XN CAL - CUSTOMER SET
Model: 213527
Lot: beginning with 7283
XN CAL PF - CUSTOMER SET
Model: 213536
Lot: beginning with 7282
XN-L CHECK
Model: 213569
Lot: beginning 7300
Why this matters
Inaccurate test results
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: beginning 7300, beginning with 7255, beginning with 7261, beginning with 7269, beginning with 7277, beginning with 7305, beginning with 7282, beginning with 7283
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 110-4008-0, 110-4009-0, 14030040, 14030060, 160-4002-0, 199-4004-1, 199-5001-0, 199-5002-0, 201-6001-0, 201-6002-0, 201-6003-0, 201-6004-0, 213499, 213527, 213536, 213569, XN CAL, XN CAL PF
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Inaccurate test results
What should consumers do?
Stop using the affected products immediately. Check the lot or serial numbers of your products. Remix the product and repeat analysis as instructed in the official notice.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Inaccurate test results
When was this product recalled?
This product was recalled on August 17, 2018.
Is the Sysmex brand affected by this recall?
Yes, Sysmex products are affected by this recall. This recall involves several Sysmex hematology controls and calibrators sold in Canada. They are being recalled because they may provide inaccurate platelet counts if not mixed sufficiently. Healthcare professionals should stop using the products and follow the instructions in the official notice.