Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 6, 2013
pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test par
The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Sysmex America Inc recalled pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysme… - a moderate-severity action.
pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysme… was recalled by Sysmex America Inc in November 6, 2013. Reason: The data printed on the thermal printer may omit a digit or decimal point in the results or sample identifica…. Check the official notice for the remedy. Verify recall #Z-0100-2014 with the FDA Devices before acting.
The recall
Sysmex America Inc issued this moderate-severity FDA Devices recall-The data printed on the thermal printer may omit a digit or decimal point in the results or sample identifica….
- Moderate
- severity level
- 193 units
- affected scope
- Class II
- classification
- November 6, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0100-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0100-2014) was formally reported on November 6, 2013, with the manufacturer initiating the action on May 15, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Sysmex America Inc is listed as the recalling firm, operating out of Lincolnshire, IL. Federal records list the affected scope as 193 units.
The documented reason for this recall is: The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number. Distribution data in the federal record shows the product reached: Worldwide distribution: US (Nationwide) including Puerto Rico and states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, SD, TN, TX, UT, VA, VT, WA, WI…. 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
193 units
Related Recalls
6
3 from same agency
Product description
pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO).
Reason for recall
The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0100-2014 |
| Date reported | November 6, 2013 |
| Date initiated | May 15, 2013 |
| Recalling firm | Sysmex America Inc |
| Firm location | Lincolnshire, IL |
| Affected scope | 193 units |
| Distribution | Worldwide distribution: US (Nationwide) including Puerto Rico and states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and countr… |
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-0100-2014) 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? ▼
pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO).. Recalled by Sysmex America Inc. Units affected: 193 units.
Why was this product recalled? ▼
The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2013. Severity: Moderate. Recall number: Z-0100-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: US (Nationwide) including Puerto Rico and states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and country of Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0100-2014) 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 November 6, 2013. 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.