Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 22, 2016
The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.
Sysmex Corporation recalled The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematolog… - a moderate-severity action.
The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematolog… was recalled by Sysmex Corporation in June 22, 2016. Reason: There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.. Check the official notice for the remedy. Verify recall #Z-1945-2016 with the FDA Devices before acting.
The recall
Sysmex Corporation issued this moderate-severity FDA Devices recall-There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values..
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- June 22, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1945-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1945-2016) was formally reported on June 22, 2016, with the manufacturer initiating the action on December 18, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Sysmex Corporation is listed as the recalling firm, operating out of Kobe-shi. Federal records list the affected scope as 1,137 units (US) 54 units (Canada) 9 inventory.
The documented reason for this recall is: There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values. Distribution data in the federal record shows the product reached: Worldwide Distribution - US to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,137 units (US) 54 units (Canada) 9 inventory
Related Recalls
6
3 from same agency
Product description
The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Reason for recall
There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1945-2016 |
| Date reported | June 22, 2016 |
| Date initiated | December 18, 2014 |
| Recalling firm | Sysmex Corporation |
| Firm location | Kobe-shi |
| Affected scope | 1,137 units (US) 54 units (Canada) 9 inventory |
| Distribution | Worldwide Distribution - US to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY + District of… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1945-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.. Recalled by Sysmex Corporation. Units affected: 1,137 units (US) 54 units (Canada) 9 inventory.
Why was this product recalled? ▼
There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 22, 2016. Severity: Moderate. Recall number: Z-1945-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY + District of Columbia + Guam; Internationally to Australia, Bahrain, Bangladesh, Cambodia, Canada, China, Germany, Hong Kong, India, Indonesia, Malaysia, Maldives, Mongolia, Mynamar, Nepal, New Zealand, Pakistan, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, and Vietnam. THE CORRECTION IS LIMITED TO XN-10/XN-20 UNITS DISTRIBUTED BY SYSMEX AMERICA, INC., INSTALLED AT END-USER SITES IN US, PUERTO RICO, AND CANADA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1945-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 22, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.